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GSK Claims New Anitbody Drug Is Effective Against Omicron

GSK Claims New Anitbody Drug Is Effective Against Omicron

GSK has just released more data on its new COVID antibody-drug and – surprise, surprise – the company and its American partner claim there is no evidence that the drug is less effectiv

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GSK Claims New Anitbody Drug Is Effective Against Omicron

GSK has just released more data on its new COVID antibody-drug and - surprise, surprise - the company and its American partner claim there is no evidence that the drug is less effective against the omicron variant.

GlaxoSmithKline and Vir Biotechnology released the updated preclinical data early Tuesday in the US. The data showed that the pair's investigational monoclonal antibody sotrovimab continues to show "in vitro activity" against the full known omicron spike protein, according to a statement. This includes 37 identified mutations of the spike protein. Although none of this data has been published in a peer-reviewed medical journal.

The data builds on initial preclinical data released last week showing GSK's antibody drug retains in vitro activity against key individual mutations of the omicron variant.

But Tuesday's data is even more encouraging.

"Given the less than three-fold neutralization shift demonstrated in the pre-clinical pseudo- virus assay, which falls below the FDA authorized fact sheet guidance of less than a 5-fold change, we are confident that sotrovimab will continue to provide significant benefit for the early treatment of patients hoping to avoid the most severe consequences of COVID-19," said Vir CEO George Scangos.

GSK's top scientist released a similarly sunny statement.

"From the outset of our collaboration with Vir we hypothesized that sotrovimab would have a high barrier to resistance and thus could deliver best-in-class potential for the early treatment of patients with COVID-19,” said Dr Hal Barron, chief scientific officer at GSK.

"These pre-clinical data demonstrate the potential for our monoclonal antibody to be effective against the latest variant, Omicron, plus all other variants of concern defined to date by the WHO, and we look forward to discussing these results with regulatory authorities around the world."

Unfortunately for the most vulnerable patients, the benefits of sotrovimab have not been seen in patients hospitalized due to a severe case COVID. Furthermore, the drug isn't used for patients who are hospitalized or require oxygen due to the seriousness of the infection.

Sotrovimab is authorized for emergency use in the US and in Japan while temporary authorizations have been granted in a dozen countries. The companies are preparing to apply for approval in the EU as well. GSK is already filling out the application for the EMA and it has already signed an agreement with the European Commission to supply doses of sotrovimab. Additional agreements are yet to be announced due to confidentiality or regulatory requirements, the company said.

GSK and Vir have engineered "pseudo-viruses" that feature major COVID mutations and have run lab tests showing the antibody drug's efficacy at combating these viruses in a lab setting.

As we pointed out again yesterday, with little concrete data available on omicron, drug- and vaccine-makers have effectively been left to talk their books, so to speak. The big question now: will these treatments actually work in humans?

Tyler Durden Tue, 12/07/2021 - 07:02

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Dr. Peter McCullough: Official COVID “Narrative Has Crumbled”

Dr. Peter McCullough: Official COVID "Narrative Has Crumbled"

Authored by Art Moore via WND.com,

Dr. Peter McCullough – a renowned cardiologist and highly published medical scientist whose confrontation of the government’s COVID-19 policies.

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Dr. Peter McCullough: Official COVID "Narrative Has Crumbled"

Authored by Art Moore via WND.com,

Dr. Peter McCullough – a renowned cardiologist and highly published medical scientist whose confrontation of the government's COVID-19 policies has drawn more than 40 million views on Joe Rogan's podcast – told WND in a video interview Thursday night the official pandemic narrative that has been fiercely guarded by establishment media and social-media censors is "completely crumbling."

That narrative, he said, included "false statements regarding asymptomatic spread, reliance on lockdown and masks – which obviously didn't work – the suppression of early treatment, the mass promotion of vaccines that failed."

"And now here we are, almost in complete free fall," McCullough said, referring to the record number of COVID-19 cases as officials acknowledge the vaccines don't prevent infection or transmission.

McCullough noted that in California, with the more contagious but much milder omicron variant now dominant, health care workers who tested positive for COVID-19 and had symptoms were told to go back to work.

"With that, I think that's it. I think that's the end. The narrative has crumbled. People don't want these vaccines," McCullough said.

"The vaccines should be pulled off the market. They clearly are not solving the problem."

The focus, he said, should be on "treating high-risk patients who develop symptoms" with some of the early treatments that he and other physicians around the world have found to be effective, including ivermectin and a new drug granted emergency use authorization by the FDA, Paxlovid.

McCullough cited a study from Denmark and data from the U.K.'s health agency showing that the vaccines have zero effectiveness against omicron.

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"That's not misinformation," he said. "I'm just quoting the data. All of this can be looked up. Fact-checkers can look at it. I know I'll never have any problems with allegations of misinformation, because I just quote the data."

President Biden clearly had McCullough in mind when on Thursday he urged social media companies and media outlets to "please deal with the misinformation and disinformation that's on your shows. It has to stop."

McCullough pointed out his work has been relied upon by courts across the nation, including the U.S. Supreme Court, and he has testified to the U.S. Senate and will be back there later this month.

"I think America knows who is giving them the straight story."

In the half-hour video interview with WND (embedded below), McCullough also discussed:

  • The punishment of physicians who counter the official COVID narrative and use clinically indicated, FDA-approved drugs off-label such as ivermectin to treat COVID-19 patients, including a colleague in Maine whose was ordered to undergo a psychological examination after her license was suspended;

  • His participation in a rally in Washington, D.C., on Jan. 23 protesting vaccine mandates;

  • The Supreme Court's rulings Thursday on vaccine mandates;

  • The possibility that omicron could spell the end of the pandemic, serving as a "universal booster";

  • Data showing that vaccination has backfired, making the pandemic worse in nations with high vaccine intake;

  • The lethality of the mRNA vaccines;

  • His view on Biden's mass testing program;

  • His take on new FDA-approved treatments and his simple, inexpensive, over-the-counter protocol for treating omicron;

  • The unwillingness of so many doctors to "come off the sidelines" and treat patients for COVID-19;

  • The "crisis of competence" among top government health officials;

  • Where to find resources and support for physicians and patients, and for employees confronting mandates.

"I think Americans are going to understand that their individual choice is really what's going to matter in the end," he McCullough told WND in conclusion. "If Americans decide that they're not going to take any boosters or any more vaccines, it doesn't matter how many mandates or how many court decisions that happen. The vaccine program is going to crumble. I think it's just a matter of saying no."

He emphasized that the vaccines are still "research."

"No one can be forced into it," he said of vaccination. "And they're not turning out to be safe or effective. So, if  everybody just stands firm and declines the vaccines, I think that will be the quickest way for us to get out of this."

See the WND interview with Dr. Peter McCullough:

McCullough, in a video interview with WND in December, called for a "pivot" from the current policies to early treatment and "compassionate care" for those who have COVID or have suffered vaccine injuries, which have included myocarditis, neurological issues and blood clotting.

"Now is the time for doctors to step up. Now is not a time for rhetoric or harsh statements regarding scientific discourse," he said.

Many of McCullough's 600 peer-reviewed publications have appeared in top-tier journals such as the New England Journal of Medicine, Journal of the American Medical Association and The Lancet. He testified to the U.S. Senate in November 2020 against what he described as the federal government's politicization of health care during the pandemic, curbing or blocking the availability of cheap, effective treatments. In a speech in September, he told of having been stripped of the editorship of a Swiss-based journal after having lost his position with a major health system, "with no explanation and no due process." Baylor University Medical Center fired him in February. And Texas A&M College of Medicine, Texas Christian University and University of North Texas Health Science Center School of Medicine have cut ties with McCullough, accusing him of spreading misinformation.

"I've been stripped of every title that I've ever had in that institution. I've received a threat letter from the American College of Physicians, [and] a threat letter from the American Board," he said in September.

All because of his "lawful" participation "in a topic of public importance."

He said there are "powerful forces at work, far more powerful than we can possibly think of, that are influencing anybody who is in a position of authority."

McCullough is the chief medical adviser for the Truth for Health Foundation, a physician-founded charity that says it is "dedicated to following the Oath of Hippocrates to serve individual patients to the best of our ability and judgement and to uphold the highest standards of medical ethics."

*  *  *

Last year, America's doctors, nurses and paramedics were celebrated as frontline heroes battling a fearsome new pandemic. Today, under Joe Biden, tens of thousands of these same heroes are denounced as rebels, conspiracy theorists, extremists and potential terrorists. Along with massive numbers of police, firemen, Border Patrol agents, Navy SEALs, pilots, air-traffic controllers, and countless other truly essential Americans, they're all considered so dangerous as to merit termination, their professional and personal lives turned upside down due to their decision not to be injected with the experimental COVID vaccines. Biden’s tyrannical mandate threatens to cripple American society – from law enforcement to airlines to commercial supply chains to hospitals. It's already happening. But the good news is that huge numbers of "yesterday’s heroes" are now fighting back – bravely and boldly. The whole epic showdown is laid out as never before in the sensational October issue of WND's monthly Whistleblower magazine, titled "THE GREAT AMERICAN REBELLION: 'We will not comply!' COVID-19 power grab ignites bold new era of national defiance."

SUPPORT TRUTHFUL JOURNALISM. MAKE A DONATION TO THE NONPROFIT WND NEWS CENTER. THANK YOU!

Tyler Durden Mon, 01/17/2022 - 23:50

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Pfizer CEO Predicts Life On Earth “Will Return To Normal” In The Spring

Pfizer CEO Predicts Life On Earth "Will Return To Normal" In The Spring

Just a few days ago, Bill Gates shared some of his (revised) thoughts on the COVID pandemic and the trajectory that omicron has left us on. Several weeks after warning…

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Pfizer CEO Predicts Life On Earth "Will Return To Normal" In The Spring

Just a few days ago, Bill Gates shared some of his (revised) thoughts on the COVID pandemic and the trajectory that omicron has left us on. Several weeks after warning that omicron's heightened infectiousness might send the pandemic into overdrive, the Microsoft founder postulated instead that omicron might hasten the end of the pandemic by leaving the human population with more antibodies against the virus. As a result, SARS-CoV-2 might enter its endemic stage more quickly, Gates suggested.

This view, that the end of the pandemic might finally be at hand after two years of suffering, has become increasingly popular as of late. Take this piece from the BBC: "Endemic COVID: Is the pandemic entering its endgame?".

While the piece mostly focused on the UK, the sense is that the developed world more broadly is closer to the end because of its access to vaccines.

So, is a new Covid-era truly imminent and what will that actually mean for our lives?

"We're almost there, it is now the beginning of the end, at least in the UK," Prof Julian Hiscox, chairman in infection and global health at the University of Liverpool, tells me. "I think life in 2022 will be almost back to before the pandemic."

What's changing is our immunity. The new coronavirus first emerged two years ago in Wuhan, China, and we were vulnerable. It was a completely new virus that our immune systems had not experienced before and we had no drugs or vaccines to help.

It even came with his handy illustration depicting the difference between "pandemic" and "endemic" COVID:

Source: The BBC

Well, it appears the CEO of Pfizer has caught on to this narrative - and he approves. Speaking to the French media, Pfizer CEO Albert Bourla that while he expects COVID to continue to circulate for many years to come, he expects future waves won't cause the types of restrictions that people have become used to over the last two years, and that life will return to "normal" in the spring.

Bourla told French news outlet Le Figaro in an interview published Jan. 16 that he expects a "return to normal life" at some point in spring of this year. However, he added the caveat that the mysterious dynamics of COVID's spread make accurate predictions more difficult.

"We will soon be able to resume a normal life," Albert Bourla told the French paper. "We are well positioned to get there in the spring thanks to all the tools at our disposal: tests, very effective vaccines and the first treatments that can be taken at home."

He also credited improvements in COVID testing, vaccines, and therapeutics for his optimistic outlook, telling BFM TV that he expects the current omicron-driven wave to be the "last with so many restrictions."

But given its affinity for its human hosts, COVID will likely be "very difficult to get rid of," which is why Bourla expects it to become endemic, with the occasional seasonal flareup, like the flu.

Finally, the Pfizer CEO shared details of local partnerships that he said would help France produce more of Pfizer's COVID fighting drug Paxlovid.

With his approval rating at an all-time low, President Biden better hope the likes of Bourla and Gates are right. Ending the COVID pandemic might be the only thing that could help Biden regain some support among the tired and frustrated American electorate.

Tyler Durden Mon, 01/17/2022 - 17:00

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The case for vaccine mandates is collapsing

It’s more about a grab for power than about public health “The unvaxxed, I really feel like pissing them off,” said French President Emanuel Macron a few days ago. “And so we’re going to keep on doing that, to the very end. That’s the strategy.”…

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It’s more about a grab for power than about public health

“The unvaxxed, I really feel like pissing them off,” said French President Emanuel Macron a few days ago. “And so we’re going to keep on doing that, to the very end. That’s the strategy.”

In an interview in September, an outraged Justin Trudeau accused unvaccinated Canadians of being “extremists” who are “often misogynistic and racist.” “They are a small group that occupy a loud space and a decision needs to be made,” he added. “Do we tolerate these people?”

A few days ago, a clip from an interview that Bill Gates gave to CNN’s Anderson Cooper in August went viral. During the interview, Cooper asked Gates if he thought the federal government should revoke social security from the unvaxxed. His breezy matter-of-factness did not give the impression that he thought taking away the livelihood of senior citizens is the outrageously cruel proposal that it manifestly is.

A few months ago, the Toronto Star, Canada’s largest newspaper, ran a series of Twitter posts on its front page showcasing the dwindling patience of the vaccinated for the unvaccinated. “I have no empathy left for the wilfully unvaccinated. Let them die,” said one. “I honestly don’t care if they die from COVID. Not even a little bit,” read another. Another suggested that the unvaccinated be refused health care.

The Star’s public editor subsequently apologized for that catastrophically misguided feature, a blot on Canada’s reputation for kindness and tolerance. But that didn’t stop the paper from running an editorial a few days ago, urging the government to “turn the screws” on the unvaccinated, singling them out for blame for “for the restraints under which Canadians are currently required to live.”

Vaccine mandates are, of course, intended to protect public health and save lives. After all, what else would they be for? One writer, Geoff Schullenberger, has recently suggested another plausible alternative: They are – or, at least, are increasingly becoming – a vehicle for signalling belonging to a political tribe and punishing one’s ideological foes.

One doesn’t like to think that public health policy could be motivated by anything so juvenile as that. And yet, the troubling escalation of and excesses in rhetoric suggest that, in some cases, it may well be. This was always the risk with the mandates, of course. The problem with coercive measures, as Schullenberger notes, “is that they risk conflating intention and outcome.” In which case, support for the mandates comes to be driven not by empirical evidence that they are working but rather by a conviction that they are, in some abstract moral sense, “the right thing to do.”

True, there may be another, more sinister motivation at work, though one hesitates to mention it. Despite the claims of our technocrats that if everybody only did what they were told, Covid would be controlled and eliminated, the virus has so far refused to comply. Even previously successful zero-COVID jurisdictions like Australia, with all their ideal geographic advantages, are now facing the reality that, with the hyper-transmissible Omicron variant, community spread and endemicity are inevitable. In the face of this uncontrollable tsunami of infections, politicians will inevitably grope about for the nearest scapegoat. If only for this reason, we must be quick to reject any hint of rhetoric “othering” the unvaccinated.

Schullenberger is right to single out the “remarkable incuriosity” of our political and chattering classes about whether the mandates passed so far have actually accomplished what they were supposedly intended to. Are mandates having an appreciable impact in increasing vaccinations, and ultimately (the only metric that really matters) curbing the spread of disease and saving lives? Meanwhile, what are the costs: to social cohesion, to long-term trust in authorities? These questions scarcely ever get asked, let alone answered.

The only recent example I can think of – an analysis in the New York Times – found that U.S. states with mandates had no higher vaccination rate than states without. But if the case for the mandates was already shaky, in the age of Omicron it has fallen to pieces. The evidence is overwhelming that, despite initial optimism and data suggesting that the vaccines could lead to herd immunity, vaccine efficacy against symptomatic infection has collapsed. Even worse, the mandates are now leading to staffing shortages in hospitals and clinics, among police, firefighters and other first responders, counterintuitively producing a public health deficit.

If vaccines no longer meaningfully slow or prevent infection, and the mandates haven’t increased vaccinations, then what’s the public health rationale for barring the unvaccinated from restaurants and movie theatres, again? There isn’t one. All that’s left is tribal virtue-signalling and (alas) vindictiveness: i.e., a desire to separate the sheep from the goats, to punish those who did “the wrong thing,” and to privilege and comfort those who “followed the rules” and did “the right thing.”

As the prime minister of New Zealand put it a few months ago in a moment of troubling candour, vaccine mandates aren’t just about increasing vaccination rates. They’re also, she said, a tool to give “confidence” to the vaccinated. “People who are vaccinated want to know that they’re around other vaccinated people,” she said while cheerily agreeing that she is creating a “two-class” society. “That is something that I think we should offer to people who have been vaccinated, that confidence that we’re doing everything we can to keep them safe.”

Protecting the feelings of one group in society over another is not, of course, any way to conduct public health policy. Remarks like this do little to inspire confidence that cool-headed, empirically-driven public health considerations are in the driver’s seat or will prevail in the end. Too often, it seems as if the mandates are simply being retrofitted into the framework of our political tribalization: just one more tool to express our a priori loyalties and to “own” the other.

Hence, at the very moment that the case for the mandates is collapsing, the mandate zealots are doubling down, chasing a particularly perverse form of the sunk cost fallacy. “Turn the screw,” urges the Toronto Star. “[R]aise the cost” of this “demonstrably anti-social behaviour.” One wonders: How high? How high are we willing to raise the cost? How will we know when to stop or when we have gone too far? The Star, for its part, suggests that everything short of banning the unvaxxed from “all social services” is on the table. But then again, experience suggests that what is not on the table today may well be on the table tomorrow. After all, it was only a few short months ago that even Trudeau proclaimed vaccine mandates to be un-Canadian. How quickly times change.

At the beginning of the pandemic many of us hoped that the crisis might help people overcome these tribal divisions and unite against a common threat. Except for a few weeks in the beginning, that largely did not happen. But it is never too late.

The mandates are not doing what they were promised to do. Indeed, there are hints they are doing the opposite: provoking psychological reactance among the vaccine-skeptical, further entrenching them in their suspicion that the vaccines are less about public health than they are about power. While they may be wrong about that, the one way I can think of to prove them right is to bring down the full weight of the coercive power of the state on their heads.

Although I am happily vaccinated and believe that most people should be vaccinated, I know many who are vaccine-hesitant. None of them have gotten vaccinated in response to Ontario’s vaccine passport, which bars them from public venues and restaurants. Some, however, who were previously considering getting vaccinated have said that they will certainly not get vaccinated now that it has come down to a choice of whether or not to cooperate with an unjust mandate. Turning up the heat may eventually convince a per cent or two more to cave, but for the remainder this has now become an existential struggle against what they perceive as an increasingly totalitarian effort. Just how far are we willing to go to break the resolve of that last few per cent?

The growing impression that some pro-mandate politicians are increasingly motivated by personal animus towards the unvaccinated, and that some governments intend to double down on coercion regardless of whether or not doing so provably advances public health, is not helping. Without a course correction, there is a very real risk that the deep divisions and distrust fomented by misguided mandates will remain with us for years, if not decades, imperilling our ability to respond effectively to future public health crises.

Even if those of us who are vaccinated disagree with the misinformation being spread or the choices being made by the unvaccinated, it is time for us to unite in opposition to coercive policies that are further dividing us, sowing fear, distrust, and anger, and which have utterly failed to achieve the public health outcomes that they were ostensibly designed to achieve.

By John Jalsevac
Contributor
Cardus

John Jalsevac is currently working on his PhD in medieval philosophy at the University of Toronto, where he is a Faculty of Arts and Science Top (FAST) fellow.

Courtesy of Troy Media.

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